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BAY43-9006 Phase II Study for Renal Cell Carcinoma

NCT00661375 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 131

Last updated 2014-12-25

No results posted yet for this study

Summary

To evaluate efficacy, safety, and pharmacokinetics of BAY 43-9006 in patients with unresectable and/or metastatic renal cell cancer (RCC) who have failed at least one cytokine containing regimen.

Conditions

  • Carcinoma, Renal Cell

Interventions

DRUG

Nexavar (Sorafenib, BAY43-9006)

BAY 43-9006 400mg b.i.d. Treatment will continue until progression of underlying disease, unacceptable toxicity whose causal relationship to the study drug cannot be ruled out and which requires discontinuation of the drug, or consent withdrawal.

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-11-30
Primary Completion
2006-03-31
Completion
2006-03-31

Countries

  • Japan

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00661375 on ClinicalTrials.gov